Expanded Access Working Group

Mandate

To identify and address practical, ethical, and regulatory issues that arise from the use, and potential misuse, of the expanded access pathway by various CGT stakeholders. The Working Group will develop informed perspectives on expanded access that will help ISCT as it generates educational resources that promote innovation in translational research while upholding the highest ethical standards.

Selected Publications

• An International Society for Cell & Gene Therapy working group short report on the future of expanded access to unapproved cell and gene therapies (2023)
  
  

Committee Members:

Bambi Grilley, RPh, RAC, CIP, CCRC, CCRP
Baylor College of Medicine
United States

Laertis Ikonomou, PhD
The State University of New York at Buffalo
United States

Aaron Levine, PhD, MPhil
Georgia Institute of Technology
United States

Wilson Bryan, MD
Independent Regulatory Consultant
United States

Elena Maryamchik, MD
Memorial Sloan Kettering Cancer Center
United States

Beth Roxland, JD, MBioethics
Roxland Consultants Ltd.
United States

Latest Webinar:

The ISCT Expanded Access Working Group partnered with the NYU Grossman School of Medicine Division of Medical Ethics' Working Group on Compassionate Use & Preapproval Access (CUPA) on "Expanded Access 101".

This is a FREE introductory webinar covering the basics of expanded access (compassionate use) from a variety of stakeholder perspectives, including the role of clinicians. The webinar features Dr. Bambi J. Grilley, ISCT Chief Regulatory Officer, and Dr. Laertis Ikonomou, Immediate Past Chair of the ISCT Committee on the Ethics of Cell and Gene Therapy.

The recording is now available: